Australian regulation of over-the-counter medicines

What is an 'over the counter' medicine?

Over-the-counter medicines (OTC) are medicines that are not prescription medicines and are not complementary medicines. OTC medicines can be supplied as:

• pharmacy medicines (included in Schedule 2 to the Poisons Standard); or
• pharmacist-only medicines (included in Schedule 3 to the Poisons Standard); or
• general sales medicines that are not included in any of the Schedules to the Poisons Standard.

Medicines are grouped into schedules according to the appropriate level of regulatory control over their availability to consumers.

How the TGA regulates over-the-counter medicines

The Act requires that all medical products to be imported into, supplied in, or exported from Australia (other than those that are exempt) must be included in the Australian Register of Therapeutic Goods (ARTG).

In order for a medicine to be included in the Australian Register of Therapeutic Goods, a sponsoring company is required to lodge an application to the TGA. The TGA has developed the Australian Regulatory Guidelines for OTC Medicines (ARGOM) to assist sponsors of OTC medicines to meet their legislative obligations.

OTC medicines can be registered or listed on the Australian Register of Therapeutic Goods, depending on the level of risk associated with making the product available and accessible to consumers.

Registered OTC medicines are considered to be of lower risk than prescription medicines, but they still require an appropriate level of scrutiny.

Registering an OTC medicine in the ARTG

An application to register an OTC medicine is submitted on-line through the TGA Business Services facility. The online application needs to be accompanied by:

• An application dossier in CTD format that contains the required information, including:
  • Data that support the safety, quality and efficacy of the product
  • Copies of all labelling
  • Copies of Product Information and Consumer Medicine Information documents, where relevant
  • Administrative information
• The payment of fees

The ARGOM contains detailed information to assist sponsors to prepare applications and describes the information to be supplied with applications for registration of new OTC medicines for human use in Australia, or to vary existing medicine registrations.

The decision to register an OTC medicine

When making the decision to register an OTC medicine, the decision maker takes into account the information provided by the sponsor as well as the advice given by the TGA scientific and medical experts and the advice given to it by the Advisory Committee on Medicines.

Appeal processes

If the sponsor does not agree with the decision made by the TGA, the Act provides a comprehensive system for review of administrative decisions. The appeal mechanisms are described in more detail in the TGA internal review guideline. Briefly, the formal appeal process usually involves:

• An appeal under Section 60 of the Act.

This can be followed by:

• An appeal to the Administrative Appeals tribunal (AAT).

Applications to change conditions of registration

Once a product has been registered, the sponsor can make further applications to change the conditions of registration. Some examples of changes that might be sought include:

• Label changes
• Shelf life changes
• Formulation changes
• Quality control changes
• Changes to indications
• Changes to directions for use

A 'Change Table' is included in the guidance Changing an OTC medicine: using the Changes Tables that provides details of changes that can be made and the information required to support a particular type of change.

Listing an OTC medicine in the ARTG

The process involved in listing an OTC medicine is different to that associated with registering a medicine.

Further information on requirements relating to listing of OTC medicines on the ARTG can be found in the Australian Regulatory Guidelines for Complementary Medicines. Information on listing and registration of sunscreens on the ARTG can be found in Understanding the regulation of therapeutic sunscreens (previously the Australian Regulatory Guidelines for Sunscreens).

Monitoring the safety of OTC products

The TGA has a multi-faceted program for monitoring therapeutic products that are on the market.

• The TGA has a problem reporting system for reporting:
  • Medicine deficiency or defect
  • Adverse reaction to a medicine
• Random and targeted sampling of approved products is undertaken by the TGA Laboratories
• Random and targeted desk-based audits of listed products
• Audits of GMP
• Controls for the advertising of therapeutic goods
• Once a problem has been identified possible regulatory actions vary from continued monitoring to withdrawing the product from the market. Actions the TGA can take include:
  • Informing health care professionals and consumers about the risks of using the product
  • Re-assessing the benefit-risk profile
  • Requiring product labelling changes
  • Requiring design or manufacturing change
  • Recalling products
  • Removal of the product from the ARTG.